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Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: AT-PD13-359A1
- Expiration date of the lot/batch: 07 Jan 2019

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient, dark, dry
Percentile:
D10
Mean:
2.3 µm
Remarks on result:
other: Std deviation not specified
Percentile:
D50
Mean:
11 µm
Remarks on result:
other: Std deviation not specified
Percentile:
D90
Mean:
367.9 µm
Remarks on result:
other: Std deviation not specified

Particle Size Distribution of FAT 20033/L:


 






























 



Measurement 1 [μm]



Measurement 2


[μm]



Average


[μm]



L10



2.365



2.276



2.3



L50 (Median


particle size)



11.231



10.764



11.0



L90



368.556



367.291



367.9



 

Conclusions:
The particle size distribution of FAT 20033/L was:
L10D (v, 0.1): 2.3 μm
L50D (v, 0.5): 11.0 μm
L90D (v, 0.9): 367.9 μm
Executive summary:

The particle size distribution of FAT 20033/L was determined according to CIPAC MT 187. The method employed was the laser diffraction method with dry dispersion. Master Sizer 2000 and autoaccessoires, Malvern, Germany was used for this purpose. Based on the findings of the study, the following particle size distribution was observed for FAT 20033/L:


L10D (v, 0.1): 2.3 μm


L50D (v, 0.5): 11.0 μm


L90D (v, 0.9): 367.9 μm

Description of key information

The mass median (aerodynamic) diameter of FAT 20033/L is 11 µm.

 

Additional information

The particle size distribution of FAT 20033/L was determined according to CIPAC MT 187. The method employed was the laser diffraction method with dry dispersion. Master Sizer 2000 and autoaccessoires, Malvern, Germany was used for this purpose. Based on the findings of the study, the following particle size distribution was observed for FAT 20033/L:


L10D (v, 0.1): 2.3 μm


L50D (v, 0.5): 11.0 μm


L90D (v, 0.9): 367.9 μm